FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Federal Court Echoes PTAB Ruling Invalidating Zytiga Patent

Nov. 7, 2018
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A New Jersey federal court threw out Johnson & Johnson’s patent on a top-selling prostate cancer treatment.

In his decision, Judge Kevin McNulty of the U.S. District Court for the District of New Jersey agreed with an earlier 2018 ruling by the Patent Trial and Appeals Board that J&J’s patent on Zytiga (abiraterone acetate) was invalid.

The patent specifically covered the combination of Zytiga’s API with the steroid prednisone, which a collection of generics manufacturers, including Teva, Amneal and Mylan, argued was not a new idea. McNulty agreed. “The patented combination here was well foreshadowed in peer-reviewed articles. That factor outweighs the others,” he wrote. “Balancing all of the prior art and the other indicia, I find that the evidence favors a conclusion of obviousness.”

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